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The United States Court of Appeals for the Federal Circuit is now open and in session.

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God save the United States and its honorable court.

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Please be seated.

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Good morning.

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Our first case for today is 2 0 1 5 dash 1 6 7 2 N-ray nuvasive.

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Mr. Risotto.

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Please proceed.

[00:00:38] Speaker 05:
Thank you, Your Honor.

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I had reserved five minutes for rebuttal.

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May it please the Court, as Your Honor noted, this is an appeal from two inter-parties reviews, the 2013 507-508 both involving new evasives

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Patent number 8187334 directed to lateral spinal fusion implants.

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Respectfully, the board's finding of unpatentability should be reversed because the decision, both decisions in both of the IPRs, erred by crafting and relying on new grounds of unpatentability and its final written decisions

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while explicitly refusing to give Newvasive an opportunity to respond.

[00:01:27] Speaker 01:
Well, is it really a new ground of unpatentability?

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It's figure 18, correct?

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Correct.

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Is that what we're talking about?

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Of the same reference that was the ground of patentability that was being considered.

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At all times, it was obviousness of these particular references in combination.

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So why is it a new ground of patentability?

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It's a new ground because the theory of unpatentability and the thrust of the invention had completely changed.

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It changed from one theory and a particular embodiment to a completely different embodiment that quite frankly addresses or presents a type of implant that is fundamentally different, not only from the embodiment of the Michelson disclosure that was originally relied upon, but every other single implant

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that was addressed or presented in any of the references.

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You're the one who, in your response before PTAB, included Michelson 16, 19, and 20.

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And 16 and 19 are on the same page.

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And in between them is 18.

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But you didn't include 18.

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Why not?

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That says something to me.

[00:02:40] Speaker 05:
Well, I'm interested to hear what that says.

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My explanation of that would be figure 18 and figure 19 are describing the same embodiment.

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Figure 18 shows one piece of a multi-piece assembly implant.

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So the point that was being made in the response, and it's a valid and unrebutted point, Your Honor, is that all of the implants in Michelson

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are designed to be oversized both in length and width.

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And that was the point.

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What you're interested in when it says to me, it says when you exclude something from the body of a document, and it turns out that that information is relevant, then it tells me that if I were at a trial level anywhere, I would immediately say to myself, gee, what's in that hole?

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It's a fair question to want to know what's there.

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I don't think there was any intent to skip over things.

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The point that was being made... Well, of course there was.

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It was left out.

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I respectfully submit the intent was not to hide anything, Your Honor.

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The point being made, and if you read the briefing on that point, was

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Taking the petitions.

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You can take it.

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We read the briefing.

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I feel very sure that that is the case.

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But the argument that was being made was in response to what was presented in the petition.

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The petition case was resize the primary implants according to the dimensions of the Michelson implant.

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And there was one implant cited in the petition.

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So taking that suggestion to its logical conclusion was the argument.

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Why wasn't Heinz asked about 18?

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you were permitted below to cross-examine him and file motions for observation and so on.

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So this gets to the issue of whether observations on cross-examination after reply constitute an opportunity to respond.

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And they don't.

[00:04:49] Speaker 03:
Well, it's some opportunity.

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It just may not be enough opportunity.

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True.

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You can't put in your own evidence.

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Exactly.

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So can I just focus on this?

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the two Medtronic petitions.

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There is a reference to, was it column 10 of Michelson, which contains the descriptions of 18 and 19.

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And let's just assume for these purposes that 18 and 19 teach the same thing in terms of a long and wide and a narrow implant, each one of them all by itself.

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Why was, just as to that, which is at the 507, that's the 507 IPR, which includes all the claims except for 16 and 17, why is that not sufficient notice for you to have understood that you should address what was in column 10 of Michelson

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which indeed you did and in fact you did it not only in 507 but in 508 where there was no such counterpart in Medtronic's petition.

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So where is the missing opportunity to be heard because maybe your patent owner's response was that opportunity without more.

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It was an opportunity but again this goes back to the original theory presented which was

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focused very specifically, if you look at the claim charts that are actually presented and how Medtronic maps the relevant elements of the claim to the disclosure of Michelson, they are relying only on column 10, lines 41 through 46, which is a discussion of the figure 16 implant.

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So what I'm recalling, and tell me if I'm wrong, was that in Medtronic's 507 petition,

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There's first of all the long primary argument about, is it fray or fry?

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Fry.

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Fry, okay.

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Fry.

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And then there's an argument that says, okay, if we put aside fry by itself, we now have fry plus other stuff, including fry plus Michelson.

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And then there's a discussion

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of Michelson saying as to these elements of your claim, A through G and something else, but I think G is the crucial one, right?

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G is the one that has the ratio of length greater than or equal to 2.5 times width, right?

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And it's in that discussion that Medtronic said, see column 10 of Michelson.

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And it shows longer than wider.

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And there's no other claim element that that could have been applied to, could have made any sense, except the 2.51.

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So why wasn't that sufficient?

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Yes.

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So two points.

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So the Frye alone theory was completely rejected at the institution.

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So again, there's two parts of the petition.

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And as an initial matter, I would note that Medtronic has not advanced this argument.

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They never asserted that that

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reference you're referring to, Your Honor, constituted notice, or that they in fact did ever rely on this modular implant embodiment?

[00:08:11] Speaker 01:
I just want to clarify one thing factually, because I'm not positive I understand the facts exactly right in light of the discussion you're having with Judge Toronto.

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Factually, I thought Medtronic only relied on Michelson, column 10, roughly 41 to 46,

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for purposes of length greater than 40 millimeters.

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I didn't remember them relying on Michelson to prove the 2.5 to 1 ratio.

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I very well may be misremembering the facts, so I want you to make it very clear.

[00:08:42] Speaker 05:
Yes.

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If you look at the claim chart, when it's the 40 millimeter length, they specifically cite to just what your honor identified, column 10, lines 41 through 46.

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For the 2.5 to 1,

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I don't know that they specifically map that up, but that's critically tied to the same thing.

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So just, I mean, what I'm looking at is, so A, 172, which is, I think, their petition in 507, and it's under the heading D, ground four, claims one through five, et cetera, are obvious over section 103 over Frye in view of Michelson.

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And it says, with respect to elements A through D, F through J. And then you go on to 172 and about, I don't know, two-thirds of the way down.

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Like Fry, Michelson discloses example lateral fusion implants having an elongated shape.

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Dimensions that are longer than wide and wider than tall with a large internal space.

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See, Michelson, basically all of column 10.

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All of column 10, yeah.

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So that includes that.

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And item element G,

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is the 2.5.

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So that's not limited to the particular five lines that you were citing before.

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That's what I was focusing on.

[00:09:58] Speaker 05:
Understood.

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And I do want to address that point because it's an important one.

[00:10:00] Speaker 05:
So just to clarify how this is read, I think the paragraph referencing, these are set up to introduce the section as we petitioner are going to do an element by element showing.

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we're going to talk about rationale.

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So that I wouldn't tie together those two paragraphs as conflated into an element by element showing, I guess, is one point of distinction.

[00:10:25] Speaker 05:
But the paragraph you're referring to, Judge Strano, is discussion of rationale to combine.

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If you look at what they're arguing there, they're essentially saying these two references are both directed to spinal fusion implants.

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They're analogous art.

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And that paragraph concludes in

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And on A174, this is all one huge paragraph, it concludes, thus the combinations made from these are merely simple combinations.

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So this is in the context of rationale to combine.

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So it's not in the context of an element by element showing.

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And two, it's so general that they say to practically every embodiment

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in term, to support the point that these are both, both references Frye and Michelson are directed to implants.

[00:11:13] Speaker 03:
Can I, can I ask this as a, I guess a slight variation?

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Correct my premise if it's wrong.

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My understanding was that even in this, what Medtronic was saying was we can find the length with ratio in column 10 of Michelson.

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Just stipulate that for purposes of this question.

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I know you kind of disagree with that.

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What the board ended up doing was saying we can find in Michelson both the 40 millimeter length and the length-width ratio, which I think maybe is that different from this and would that difference matter?

[00:11:53] Speaker 05:
It's a very critical point you're picking up on, Your Honor.

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So what the board rejected, let's think about what the board rejected in terms of arriving at a combination.

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They rejected this buffet approach where you start with an implant

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and then look to another implant of Michelson and take one dimension, but not all of the dimensions.

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That was the original theory presented in the petition, and the board rejected that.

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We know they rejected that because they specifically said in the context of claim 18, which they upheld,

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that there's no rationale to pick one dimension from an implant.

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They ended up invalidating the claims they did because they felt that they could find the dimensions, the length, the width ratio, and the 40 millimeters all in a single module piece.

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That's how they came to this.

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They were unwilling to pick selectively dimensions from an implant.

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They were only willing, in the absence of a specific rationale to do otherwise, take an implant

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in Michelson and resize the primary reference accordingly.

[00:12:51] Speaker 02:
I want to get a little bit of APA in here since we haven't touched it at all.

[00:12:55] Speaker 02:
Yeah.

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Take it as a given that if we affirm PTab's decision in either IPR, then it's invalidated, it's obvious, and the other one goes.

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But you've also got APA arguments.

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Is there any reason we should treat

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507 different than 508 under the APA analysis, or does it rise and fall the same way?

[00:13:25] Speaker 05:
It's a fair question.

[00:13:26] Speaker 05:
So as far as notice opportunity to respond, I would say for the reasons we argued in our briefing, there was no opportunity, again, looking at the case, and this is just to make this point clear, and I'll get more specifically to yours, but just to make clear,

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This is a new theory, as we argued, that came up in reply.

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We asked multiple times for an opportunity to respond and didn't get that.

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And you can see that in the record.

[00:13:54] Speaker 05:
What do you do with Genzyme?

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With Genzyme, I would embrace Genzyme.

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Genzyme is a situation where

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It's very different.

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I would actually embrace Dell versus Acceleron more because the facts are more similar.

[00:14:08] Speaker 03:
They come out differently.

[00:14:09] Speaker 05:
They come out differently but the facts explain why they come out differently.

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Dell, you had a situation where the very same reference was being utilized.

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and there was a pivoting between components of the reference to meet a claim limitation.

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That changed in the reply brief that then further changed in oral hearing.

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Genzyme was different.

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That theory was the same starting from the beginning that in vitro data was predictive of the in vivo success.

[00:14:38] Speaker 05:
So it was a situation of yes it is, no it isn't, yes it is.

[00:14:42] Speaker 05:
Yes it is predictive, institution, I'm sorry,

[00:14:46] Speaker 05:
Institution decision, yes it is.

[00:14:48] Speaker 05:
Reply, pattern and response, no it isn't.

[00:14:51] Speaker 05:
Reply, yes it is.

[00:14:52] Speaker 05:
So it's the same issue, the same thrust of the invention, just like similar to the Belden case as well.

[00:14:58] Speaker 05:
You've got the same issue that's being substantiated throughout the record that's very different from starting with a particular theory and then recognizing a deficiency and turning to different content within the reference

[00:15:12] Speaker 01:
But I'd like to go on for a second to Judge Wallach's question, because your time is up and your rebuttal time is almost up on top of it.

[00:15:17] Speaker 01:
But let me ask one last question, which is, so there's a difference in the 507 and 508.

[00:15:22] Speaker 01:
In 507, as Judge Toronto pointed out on page 172, they actually reference Michelson and the particular section in the context of the ratio discussion, arguably

[00:15:34] Speaker 01:
In 508, though, there is no reference to Michael Flynn at all.

[00:15:40] Speaker 01:
Certainly, 508 undoubtedly is a better case for you, right?

[00:15:43] Speaker 01:
Because in 508, the petitioner never even referenced this portion of the reference.

[00:15:48] Speaker 01:
Does that matter?

[00:15:49] Speaker 01:
I think that's part of where Judge Wallach was in the beginning, and it's part of what I want to know from you too.

[00:15:54] Speaker 01:
Which means, does your best case scenario matter, or is it irrelevant?

[00:15:59] Speaker 01:
Because if I conclude you did have an opportunity in 507 to respond, 508's irrelevant.

[00:16:05] Speaker 05:
Yeah, well I would say there's no way that, I'm sorry, but there's no way that that general citation in the front should count as notice.

[00:16:13] Speaker 01:
Yes, but that's not what I've asked.

[00:16:14] Speaker 05:
You should try to focus on answering my question.

[00:16:15] Speaker 05:
I know it's not.

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Assuming that it does,

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on that point it would, if that's the pivotal point, it would matter between the two references.

[00:16:24] Speaker 05:
But it gets to a fundamental point also.

[00:16:26] Speaker 03:
I'm sorry, it would matter between the two references.

[00:16:28] Speaker 05:
I'm sorry, I said references, I meant petitions.

[00:16:31] Speaker 03:
Well, am I right?

[00:16:32] Speaker 03:
508 is the only one that includes claims 16 and 17.

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507 doesn't, is that right?

[00:16:36] Speaker 03:
Correct.

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So there's actually two different claims that are unaccounted for in 507.

[00:16:40] Speaker 05:
Correct, there would be overlap.

[00:16:42] Speaker 03:
But what about notice?

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I mean, you filed exactly the same, but on this point,

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patent owner's response in your 507 and 508 patent owner's response, even though you had less material to respond to in 508.

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Doesn't that show you had the notice of the point in 508, or is that not a fair point?

[00:17:00] Speaker 05:
I don't think it's notice, Your Honor.

[00:17:02] Speaker 05:
I think really what was being done is trying to characterize what is the state and invention of Michelson and point out that what the state of the art of lateral implants, if Michelson is presenting that,

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What that's teaching you is to make your implants as wide as possible, maximize coverage of the disc space.

[00:17:20] Speaker 05:
So the combination was ultimately going in a direction opposite of what the state of the art was recognizing at the point.

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So it was really a rationale point that was being made.

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There's no reason to resize the primaries to make them long and narrow in view of Michelson.

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And the critical point, I really want to make sure I hit this before we conclude, is

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to the question of does this all matter?

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There is the process issue, but there also is at the end of the day a factual record that looks exactly what you would expect it to look like when something comes up very late in the process, and that is an undeveloped and unexplained theory of non-obviousness.

[00:18:00] Speaker 05:
In other words, there's no explanation.

[00:18:04] Speaker 05:
In the final written decisions or in Medtronic's petitions,

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or any of the materials, or we'll probably be brief, why a person would resize the primary reference according to a modular, one piece of a modular implant.

[00:18:19] Speaker 02:
Well, why were these adoptions of arguments rather than evaluations of the record, which included Michelson 18?

[00:18:29] Speaker 05:
Why were these adoptions, excuse me?

[00:18:31] Speaker 02:
Why were the PTAP's final written decisions adoptions of arguments?

[00:18:35] Speaker 05:
Why were they adopting these arguments?

[00:18:37] Speaker 02:
Yeah, rather, they were not presented.

[00:18:39] Speaker 02:
Because that's what you're saying.

[00:18:41] Speaker 02:
As opposed to, they're saying they're evaluating the evidence, which is what they did.

[00:18:45] Speaker 05:
Well, I don't know if they say they're, we don't know why.

[00:18:48] Speaker 05:
I mean, this is a problem as came up in the Varanada case as well.

[00:18:52] Speaker 05:
We don't know why they brought these together.

[00:18:55] Speaker 05:
To maybe discern.

[00:18:57] Speaker 05:
There's nothing in the record in the decisions or in the reply materials why a person with an ordinary skill would look to one piece of a modular implant, a completely different type, and then resize a different type of implant according to one piece of a different type of implant.

[00:19:15] Speaker 05:
There is no explanation.

[00:19:18] Speaker 03:
Can I ask you one question?

[00:19:20] Speaker 03:
Sure.

[00:19:21] Speaker 03:
Just about, I guess, the 508.

[00:19:24] Speaker 03:
It wasn't Frye that was being relied on so much as SVSPR and Telemann, if I'm not mistaken.

[00:19:33] Speaker 03:
Both of those, I think I'm correct in saying the board did not find the following, but tell me if I'm wrong in thinking that SVSPR and Telemann make it beyond dispute.

[00:19:46] Speaker 03:
Both of those show

[00:19:48] Speaker 03:
certain implants with a length to width ratio of greater than 2.5.

[00:19:53] Speaker 03:
They're not long, but they are much longer than what?

[00:19:59] Speaker 05:
Yes, they do, but this still doesn't answer the rationale, right?

[00:20:04] Speaker 05:
If the board does what they did, which is a claim mapping exercise to identify elements between different types of implants, they can find that ratio in the SVS and Telemont.

[00:20:17] Speaker 05:
where rationale comes in is SVS and Telemont are a completely different type of posteriorly inserted implant where those dimensions make sense for that purpose.

[00:20:27] Speaker 05:
You go to Michelson, it's a completely different type of lateral implant where Michelson is telling you, you no longer are coming in from the back, you no longer are working around a spinal cord and these other anatomical restrictions.

[00:20:39] Speaker 05:
Maximize the placement of the disc space and make this as wide as possible.

[00:20:44] Speaker 05:
So there's a rationale issue as to why

[00:20:47] Speaker 05:
a person would resize one type of implant to essentially turn it into a completely, well, that's even going too far to turn it into a different, it becomes a hybrid implant with no rationale as to why you would do that.

[00:21:01] Speaker 01:
Okay, counsel, I think we're way beyond your time, so why don't you sit down and we'll hear from the PTO.

[00:21:07] Speaker 05:
Yeah, I would ask... No, counsel, sit down.

[00:21:10] Speaker 01:
Let's go.

[00:21:17] Speaker 00:
Your Honor, may it please the Court?

[00:21:19] Speaker 00:
The PTO originally intervened in this case in order to address certain procedural issues.

[00:21:24] Speaker 02:
So Mr. Mattel, Mr. Rosato embraces Genzyme, but even more dearly embraces Dell.

[00:21:37] Speaker 02:
And in your green brief, you argue that New Vesa was provided adequate

[00:21:45] Speaker 02:
APA procedural protections, tell me how this case is distinguishable from Dell, and more importantly, between those two cases, where do we draw the line for adequate procedural protection safeguards under APA?

[00:22:01] Speaker 00:
Your Honor, it's simply case-by-case determination.

[00:22:04] Speaker 00:
Genzyme, the latest, the court's latest statement on this, provides the relevant standard.

[00:22:09] Speaker 00:
The inquiry under both the APA and the due process clauses

[00:22:12] Speaker 00:
Did the party have adequate notice of the issues that would be considered?

[00:22:17] Speaker 00:
And did it have an opportunity to respond at a meaningful point in the proceeding?

[00:22:20] Speaker 00:
Now, we all agree that the period of the Patent Order response is a meaningful opportunity to respond.

[00:22:25] Speaker 00:
So the relevant question is, did Medtronic's petition, combined with the institution decision, give you this adequate notice?

[00:22:33] Speaker 01:
Well, let's start on the 508 only, because that's your worst case.

[00:22:36] Speaker 00:
So let me start on your... Your Honor, I believe 507 is the one that involved Frye and Michelson, and it's 508.

[00:22:41] Speaker 01:
That's why I want you to start on 508, which is your worst case for providing notice.

[00:22:47] Speaker 00:
Yes.

[00:22:48] Speaker 00:
Your Honor, there's an important point I'd like to raise with regard to 508.

[00:22:51] Speaker 00:
It goes to the merits.

[00:22:52] Speaker 00:
It's not something the PTO addressed, because again, we assume the parties would address the merits.

[00:22:56] Speaker 00:
But because Medtronic's not here, I'd like to point out in section two of Medtronic's brief, they point out that

[00:23:02] Speaker 00:
In 508, the board entered an independent and separate finding that the claims were unpatentable based on the combination of SVSPR and Telemann is modified in view of Michelson.

[00:23:14] Speaker 00:
And as Medtronic notes in its brief, that combination is never addressed in UVasiv's briefing in that court.

[00:23:20] Speaker 00:
That combination affords an independent basis for invalidation of the challenged claims.

[00:23:25] Speaker 00:
And it's simply no rationale, no reason has been presented for disturbing the board's findings in this case.

[00:23:31] Speaker 00:
I think the report's important enough that it's worth even taking a look at the board's written decision in 508.

[00:23:37] Speaker 00:
In that case, the board begins framing the issue at page 5 of its decision.

[00:23:41] Speaker 00:
This is about page 21 of the record.

[00:23:43] Speaker 00:
And the board points out Petitioner is arguing in this case that you can take either SVSPR or Telemann, both of which disclose the long and narrow limitation.

[00:23:52] Speaker 00:
And this is the board again.

[00:23:54] Speaker 00:
It's saying Petitioner says you can modify this in view of Medtronic's suggestion of a longer implant.

[00:24:00] Speaker 00:
And it notes that Medtronic suggests this modification for purposes of stability and for, as the board puts it, as applied dimensional optimization in accordance with the prior art.

[00:24:08] Speaker 03:
And when you say the board found this about SVSPR, what you're referring to is its quotation of what Medtronic argued in the petition, not its own findings.

[00:24:19] Speaker 00:
Is that right?

[00:24:19] Speaker 00:
This is where it framed the issue.

[00:24:20] Speaker 00:
The board's finding appears at about page 26 through 27 of the record.

[00:24:25] Speaker 00:
At page 24, it addresses Nubasev's argument.

[00:24:28] Speaker 00:
Nubasev argued, oh, you can't combine these.

[00:24:30] Speaker 00:
You can't lengthen SPSDR.

[00:24:32] Speaker 01:
Where?

[00:24:32] Speaker 01:
You said 26 to 27.

[00:24:33] Speaker 01:
26 to 27.

[00:24:34] Speaker 00:
Tell me right where.

[00:24:35] Speaker 00:
Page A, 26 through 27 of the Joint Appendix.

[00:24:38] Speaker 00:
I think it would be about page 10 of the board decision, beginning towards the bottom of page 10.

[00:24:43] Speaker 00:
And the board began addressing the two parties' arguments.

[00:24:47] Speaker 00:
Nubasev had argued that, no, you can't combine them because the

[00:24:51] Speaker 00:
SVS, PR, and Telemann are posteriorly inserted implants, and if you lengthen them too much, then they injure the anterior space of the disc.

[00:24:59] Speaker 00:
This argument is fleshed out in the patent owner's response.

[00:25:02] Speaker 00:
They argue that if you make this posterior implant too long, it'll injure the aorta and the vena cava, the great muscles.

[00:25:09] Speaker 01:
Well, and this is, forgive me if I'm wrong, this is all about the 40 millimeters in length, right?

[00:25:15] Speaker 01:
Does this have anything at all to do with the ratio of 2.5 to 1?

[00:25:18] Speaker 01:
This discussion that you're pointing me to?

[00:25:20] Speaker 00:
Yes.

[00:25:21] Speaker 00:
It's at this passage that the board finds that it weighs the two parties' arguments and it concludes, it agrees with the petitioner that you can modify both SVSPR and Telemont in accordance with Medtronic's suggestion of a longer length.

[00:25:34] Speaker 00:
First, it finds that it doesn't matter that SVSPR and Telemont are posteriorly inserted because the claims don't require that.

[00:25:40] Speaker 00:
It could be a lateral implant.

[00:25:42] Speaker 00:
And then the board, I think this is at the top of page 27,

[00:25:45] Speaker 00:
goes on to directly address this argument about posterior implants.

[00:25:48] Speaker 00:
And here the board cites the Tomei reference.

[00:25:51] Speaker 00:
Tomei is another posteriorly inserted implant.

[00:25:54] Speaker 00:
And the board concludes that in view of Tomei, Tomei shows an embodiment that has a 45 millimeter length, and that this rebuts the argument.

[00:26:00] Speaker 01:
I guess I'm looking at these pages, but it's not jumping out at me where you started your discussion, which was with a claim that you agreed or you wanted to point me to Medtronic's argument that the board made a separate fact finding

[00:26:14] Speaker 01:
that SBS and Telemann taken together with Michelson resulted in obviousness separate and apart from the failure of Michelson alone to have disclosed all the elements.

[00:26:28] Speaker 01:
So where can you grab your appendix?

[00:26:30] Speaker 01:
Do you have it?

[00:26:31] Speaker 01:
You can borrow mine if you don't have it.

[00:26:33] Speaker 00:
I have it right here, Your Honor.

[00:26:35] Speaker 01:
Where precisely do you

[00:26:37] Speaker 01:
What language, imprecise, would be that finding that you're talking about?

[00:26:42] Speaker 00:
It's the paragraph that begins at the bottom of page 10 of the board's discipline.

[00:26:45] Speaker 00:
This is page 26 of the record.

[00:26:47] Speaker 00:
Actually, just above that, the board begins by saying, you can insert these implants laterally.

[00:26:55] Speaker 00:
And if you can do it laterally, then these arguments about posterior implants are relevant.

[00:27:00] Speaker 00:
And then it goes on to cite this Tome patent and says,

[00:27:02] Speaker 00:
You know what, New Vesa's whole argument was that you can't make a posteriorly inserted implant longer than 40 millimeter, but the Tomei reference here discloses an implant that's longer than 40 millimeters.

[00:27:13] Speaker 00:
We believe that shows that you can make this combination, and therefore we agree with Petitioner that you can modify the SVSPR Telemann references in view of Medtronic's teaching of making a longer implant.

[00:27:24] Speaker 03:
Let me see, I think I'm focusing on the same thing that Judge Morris is focusing on.

[00:27:31] Speaker 03:
That discussion seems to be about using Michelson for the 40 millimeter, not for Slankton Wick.

[00:27:37] Speaker 03:
It's back earlier on page 22, or six of the original number, where the board seems to, in its own finding, rely

[00:27:49] Speaker 03:
only on Michelson, the same passage we were discussing for the length with ratio, we credit the testimony of Heinz, blah, blah, blah.

[00:27:58] Speaker 03:
And they don't, the board does not appear to say for the length with ratio, we find that, we credit the testimony or assertion by petitioner in STS and Telemont.

[00:28:10] Speaker 00:
The board did import this alternative finding from the 507 IPR that

[00:28:15] Speaker 00:
You know, look, the nuvasive is, I mean, Medtronic is saying that you can combine these.

[00:28:19] Speaker 00:
This is what's at page five of the decision, where the petitioner's argument is framed, that you rely on each reference for one of the two structural limitations.

[00:28:26] Speaker 00:
The board goes on to say, it's all in Michelson anyway.

[00:28:28] Speaker 00:
We found that in the other IPR.

[00:28:30] Speaker 01:
But that's all I see them saying.

[00:28:31] Speaker 01:
With regard to the length with, I don't read this opinion as ever attributing that finding to anything other than Michelson.

[00:28:40] Speaker 01:
And unlike the 507 IPR,

[00:28:43] Speaker 01:
where there is a specific reference in the petition to column 10 of Michelson and even with regard in the petition to the length with discussion there's no similar reference in 508 anywhere to Michelson at column 10 for purposes of length with or figure 18 or anything else and that's

[00:29:02] Speaker 01:
the due process problem that you have.

[00:29:04] Speaker 01:
The due process problem, as argued by petitioner, is at its absolute peak and strongest with regard to this set of facts, which is why I'm not letting you bother with 507 because I know your arguments there and I understand them completely, but this is your harder case.

[00:29:17] Speaker 01:
Your agency relied, in my view, after reading this opinion, entirely on a section of Michelson which was never cited in the petition and upon which the petition was not granted in reliance on.

[00:29:30] Speaker 01:
And that seems to be the whole rationale

[00:29:32] Speaker 01:
So how did Nubasive have an opportunity to respond to the ultimate decision the board made here, which in my view is only that Michelson discloses the length with the 2.5 to 1, when that was never part of what the petition argued originally in this IPR.

[00:29:50] Speaker 01:
And if, you know, I mean, maybe your best argument is, well, they made it in 507 so we can rely on it in 508, but that's going to make me have connections if you make that argument, because

[00:29:59] Speaker 01:
You know, I kind of don't think that you can say, well, we did it in this one case, so we can do it over here.

[00:30:04] Speaker 01:
But, you know, go ahead, try your best to tell me why.

[00:30:07] Speaker 01:
Why I can not, why there isn't a due process problem.

[00:30:11] Speaker 00:
Well, Your Honor, these two IPRs involve the same patent and the same principal reference to Michael's.

[00:30:17] Speaker 01:
Okay, but wait, but you have lots and lots of IPRs that involve the same patent.

[00:30:21] Speaker 01:
you know, sometimes we'll have four cases on the same day, which are IPRs sometimes brought entirely by different petitioners, all against the same patent, some for anticipation, some for obviousness, and if it's a CBM, have to throw a 101 in there for good measure.

[00:30:35] Speaker 01:
So, you know, it's often the case that you have multiple cases raising allegations of invalidity against multiple

[00:30:43] Speaker 01:
against the same patent.

[00:30:44] Speaker 01:
That doesn't mean I'm going to import the arguments made by one petitioner in one case into arguments made by a different petitioner in a different case, right?

[00:30:52] Speaker 01:
Clearly I wouldn't do that.

[00:30:53] Speaker 00:
I agree it could be problematic in some cases.

[00:30:55] Speaker 00:
This case though just involved two IPRs with the same party and it would be passing strange for the board to conclude in one IPR that Michelson discloses all of the disputed limits of the same patent and yet completely ignore that finding in the other IPR.

[00:31:07] Speaker 00:
The prior art teaches what it teaches.

[00:31:09] Speaker 01:
But why?

[00:31:10] Speaker 01:
It's a finding, just like you said.

[00:31:12] Speaker 01:
It is a fact

[00:31:13] Speaker 01:
finding and if certain facts were never ever alleged in a given case look we get cases sometimes where on identical facts they end up coming out this a different way right because the standard of review maybe I have to give deference to both set of facts or maybe one attorney was better in a given case and made an argument that allowed me to find in his favor in that case and on the exact same set of facts a lesser attorney didn't have the good sense to make the same argument and preserve it so I can't make that finding

[00:31:39] Speaker 01:
This is what judges are forced to do, right?

[00:31:41] Speaker 01:
Just like your agency is forced to work with the record you had in front of you and the petition that you granted.

[00:31:48] Speaker 01:
You don't get to go off record.

[00:31:49] Speaker 01:
So why?

[00:31:50] Speaker 01:
You still haven't convinced me, obviously.

[00:31:53] Speaker 01:
So try again.

[00:31:55] Speaker 00:
Do you have anything else?

[00:31:56] Speaker 00:
I would further note that these cases were even consolidated for argument, although they started as two IPRs that, again, they involved the same parties, the same patents, the same primary reference, Michelson.

[00:32:06] Speaker 00:
And once the board, the two parties had the full ability to debate Michelson.

[00:32:10] Speaker 00:
Once the board entered its findings in Michelson, those findings applied to that patent.

[00:32:14] Speaker 00:
And they naturally became an alternative rationale in the 508 IPR as well.

[00:32:19] Speaker 01:
OK, you lost me for a second procedurally.

[00:32:21] Speaker 01:
The two parties had the ability to debate Michelson when?

[00:32:24] Speaker 00:
In the 507 IPR.

[00:32:25] Speaker 00:
It's the same parties arguing about the same references as disclosing the limits in the same patent.

[00:32:31] Speaker 01:
So forgive me if I'm wrong.

[00:32:32] Speaker 01:
My recollection of this factual record

[00:32:35] Speaker 01:
is that they asked to file a surreply after suddenly this passage of Michael Simas relied on, let's just say only for the 508, let's keep it on your worst set of facts.

[00:32:46] Speaker 01:
But they asked to file a surreply.

[00:32:48] Speaker 01:
The request to file a surreply was de facto denied at the initial point.

[00:32:53] Speaker 01:
It's my recollection.

[00:32:54] Speaker 04:
It was denied, Your Honor.

[00:32:55] Speaker 01:
At my initial point, it wasn't denied, right?

[00:32:57] Speaker 01:
At the initial point, they said, we'll make a decision and we'll let you know an oral argument or something weird like that.

[00:33:02] Speaker 01:
they gave some very circumspect and weird response.

[00:33:04] Speaker 00:
The board generally asked the party staff's permission and then addresses the issue as part of the merits in many cases.

[00:33:10] Speaker 01:
And so it wasn't really technically denied, like they didn't have a clear denial at that point.

[00:33:14] Speaker 01:
But then they go into oral argument.

[00:33:16] Speaker 01:
And even though Medtronic in oral argument had brought up Michelson, column 10, figure 18, when the patent owner sought to stand up in oral argument and respond to it, I believe that he was cut off.

[00:33:30] Speaker 01:
I remember the exact transcript.

[00:33:31] Speaker 01:
by the board judge saying, wait a minute, doesn't that go to what you asked to file your CER reply on?

[00:33:38] Speaker 01:
Well, let's move on.

[00:33:40] Speaker 01:
So how did they have a full and fair opportunity to address the issue at the hearing when it is my recollection, and if my facts are wrong, you will correct me, no doubt, but it is my recollection that they were actually cut off at the oral argument from being able to respond to those points.

[00:33:54] Speaker 00:
The board's rules prohibit presenting new arguments and evidence at the oral hearing.

[00:33:59] Speaker 01:
In fact, I believe the board has been reversed by this court in cases where it has entertained... So how did they have a full and fair opportunity to respond to Michelson figure 18 and whether there were problems with the board's reliance on that for purposes of length and width when they weren't allowed to address it because you were viewing it at that point as a new argument?

[00:34:16] Speaker 00:
Your Honor, their opportunity to respond was in the patent owner response.

[00:34:19] Speaker 01:
How?

[00:34:20] Speaker 01:
At the petition stage in 508, there was no mention of Michelson, column 10, or figure 18.

[00:34:25] Speaker 01:
So why would they have responded in the patent owner response to something that didn't appear in the petition?

[00:34:31] Speaker 00:
Effectively, Your Honor, I'd agree.

[00:34:34] Speaker 00:
If the findings based on Michelson fall in 507, they fall in 508.

[00:34:38] Speaker 01:
That's not my point, and that's never been my point.

[00:34:40] Speaker 01:
So you agreeing with that doesn't actually advance our discussion at all.

[00:34:44] Speaker 01:
As Judge Toronto pointed out earlier, IPR 508 involves two

[00:34:50] Speaker 01:
claims, 16 and 17, which were not otherwise invalidated in 507.

[00:34:55] Speaker 01:
So even if 507 stands, we still have to reach whether or not due process was attendant in the 508 analysis, because there are two claims at issue there that weren't at issue in the earlier one.

[00:35:05] Speaker 01:
So you're saying you agree if Michelson doesn't carry the day in 507, then it doesn't carry it in 508.

[00:35:10] Speaker 01:
Michelson wasn't argued the same way in the two cases.

[00:35:13] Speaker 01:
So that's not the point.

[00:35:15] Speaker 00:
Your Honor, I'd return to my point that Michelson's ability to disclose all of the structural limitations was only imported as an alternative argument into the 508 IPR.

[00:35:25] Speaker 00:
Again, the board began by framing the issue as petitioner is relying on both for the combination.

[00:35:29] Speaker 00:
That's at page five.

[00:35:30] Speaker 00:
That's how it frames the issue.

[00:35:31] Speaker 00:
It addresses patents, orders, argument that you can't combine them.

[00:35:34] Speaker 00:
And at pages 10 and 11, it concludes that you can combine them.

[00:35:38] Speaker 00:
The Tomei shows that you can make a posterior implant.

[00:35:41] Speaker 01:
Procedurally, what happens

[00:35:43] Speaker 01:
In the event that I end up disagreeing with you that due process concerns weren't satisfied here, is it a reversal?

[00:35:50] Speaker 01:
Is it a vacate and remand?

[00:35:52] Speaker 01:
What happens?

[00:35:53] Speaker 01:
Because Medtronic is gone now, they have settled, and you're sort of standing in their shoes, which you've done a really admirable job of doing, given that that wasn't your brief.

[00:36:02] Speaker 01:
And a lot of the questions I asked you today didn't necessarily flow directly from what you had argued in the amicus, but rather were addressing kind of some of Medtronic's arguments.

[00:36:10] Speaker 01:
So I recognize all of that, and you've done a very good job in that regard.

[00:36:14] Speaker 01:
But what happens if I disagree with you?

[00:36:17] Speaker 01:
Do we vacate?

[00:36:18] Speaker 01:
Do we reverse?

[00:36:19] Speaker 01:
Does it go back and does the process continue at the PTO?

[00:36:22] Speaker 00:
At the very least the PTO would urge a remand and for the board to, if this board concludes for example that Medtronic or Inuvasive should have been entitled to the seroply, the board can consider that seroply.

[00:36:33] Speaker 00:
Consider these arguments that a modular implant is somehow outside the claims.

[00:36:40] Speaker 03:
Would this be the first time that the board has ever considered

[00:36:46] Speaker 03:
submissions of evidence on remand from this court in an IPR?

[00:36:53] Speaker 03:
Maybe you should do it more often.

[00:36:54] Speaker 03:
I'm just asking if it's the first time.

[00:36:56] Speaker 00:
Yeah, I'm really not sure.

[00:36:58] Speaker 00:
Certainly cases have been remanded for further consideration by the board and in this case we have a relatively complete record.

[00:37:05] Speaker 00:
There's only the additional arguments about what figure 18 does or doesn't teach.

[00:37:10] Speaker 03:
What can you tell us about

[00:37:14] Speaker 03:
What standard the board would apply in deciding whether it can go ahead on remand without a petitioner there anymore?

[00:37:25] Speaker 00:
That's a novel question that I hesitate to address in the first instance, Your Honor.

[00:37:29] Speaker 00:
It's something the office would definitely have to consider.

[00:37:33] Speaker 00:
Again, the office, I know you've read our brief, but we believe that there was adequate notice from the petition and the institution decision that Michelson could be relied on for all of the structural limitations.

[00:37:43] Speaker 02:
Let me just take you down another road before we stop and that is evasive challenges whether PTAP articulated motivation to combine and the substantial evidence provided.

[00:38:01] Speaker 02:
Why would a PASIDA be motivated to combine the references and where did the PTAP articulate that reasoning?

[00:38:12] Speaker 00:
I know that at least in the 508 IPR they did credit or they did at least offer, explain Medtronic's argument that you would lengthen a long and narrow implant for the purposes of structural stability and simply for purposes of optimization in accordance with the teachings of the prior art.

[00:38:30] Speaker 00:
The prior art teaches you all kinds of different shapes and sizes of implants for different purposes.

[00:38:35] Speaker 00:
The specification in this patent doesn't

[00:38:36] Speaker 00:
doesn't even attribute, doesn't even really discuss the limitations.

[00:38:40] Speaker 00:
It was just known to size implants in different sizes.

[00:38:43] Speaker 00:
And again, for the type of lateral implants that are contemplated here, it was known that you could insert a longer implant and that a longer implant gives you stability.

[00:38:52] Speaker 00:
I know that finding is at least discussed in the 508 IPR.

[00:38:55] Speaker 00:
I assume that there's a similar discussion in the 507 IPR, although I don't have it in my fingertips.

[00:39:00] Speaker 00:
But again, because in 507, you were relying on Michelson for all of the structural limitations,

[00:39:04] Speaker 00:
There's no need for a motive to combine what's already within Michelson.

[00:39:08] Speaker 00:
Now other references were discussed for some of the add-on references.

[00:39:11] Speaker 00:
There are seven principal features of these patents.

[00:39:13] Speaker 00:
It all came down to these two structural limits.

[00:39:16] Speaker 00:
But those additional references, the anti-migration elements and radio opaque markers and those things weren't disputed in this case.

[00:39:25] Speaker 00:
It all came down to two structural limits and the board concluded both of those limits are identified in the Michelson patent.

[00:39:32] Speaker 01:
Okay, Mr. Mattel, thank you very much.

[00:39:34] Speaker 01:
We went over by three minutes, so to even up time, Mr. Rosato, I'll give you two minutes of rebuttal time back.

[00:39:50] Speaker 05:
Thank you very much for the additional time, Your Honor.

[00:39:54] Speaker 05:
So just to get to Judge Toronto's question, and maybe you were ahead of me on this one, Judge Toronto,

[00:40:02] Speaker 05:
For the 507 case at A170, it indicated that there was a discussion, the following discussion, where this block citation to the Michelson column 10 occurs, that there was a lead-in with the element by element and then a follow-on with rationale to combine.

[00:40:22] Speaker 05:
I would just point out on page 170,

[00:40:28] Speaker 05:
A170, that is.

[00:40:29] Speaker 05:
Element G, which is the ratio issue, is missing.

[00:40:33] Speaker 05:
So they are specifically... Isn't it between F and J?

[00:40:41] Speaker 05:
Yeah, it says, right below, that sentence refers back to fry.

[00:40:50] Speaker 03:
So it is the fry reference on which they're... And it says, alternatively and additionally, as explained below,

[00:40:59] Speaker 03:
combination of Frye and Michelson.

[00:41:01] Speaker 03:
I took that first sentence just to be, by the way, we're not giving up on the argument, we just spent a lot of pages on, but if you don't believe that, now we're going to talk about the combination.

[00:41:09] Speaker 03:
And G is in here, and that's why when you get to page 176, they start, or not 176, I'm sorry, 174, they then pick up

[00:41:23] Speaker 03:
element E, which is not in the list of A through D, F through J, but that G is included.

[00:41:29] Speaker 03:
That was my... Yeah.

[00:41:32] Speaker 05:
And I think what they're doing is referring back saying, we already told you why Fry meets all these other things, and we're sticking with that, but we're pulling in Michelson for this additional element.

[00:41:44] Speaker 03:
Can I ask this question?

[00:41:46] Speaker 03:
I guess it's maybe the same thing or a version of the question having to do with the 508.

[00:41:52] Speaker 03:
I know you'd like to win on 507 as well, but the board didn't itself say we find in STS and Telemann a implant with a length to width ratio greater than or equal to 2.5.

[00:42:07] Speaker 03:
It said we find that in Michelson.

[00:42:11] Speaker 03:
It describes that in STS, Telemann.

[00:42:13] Speaker 03:
And as I look at STS and Telemann, I'm having trouble understanding how it's not plain on the face of it.

[00:42:19] Speaker 03:
8 millimeters to 22 and 10 to 26.

[00:42:22] Speaker 03:
I mean, it's right there.

[00:42:24] Speaker 03:
So what's the doubt about that?

[00:42:26] Speaker 05:
Maybe they just... Yeah, I mean, I think the ratio is there and that is what Medtronic asserted.

[00:42:33] Speaker 05:
What they try to do is point to a different reference of Michelson and the problem there when it comes to rationale is why you're selectively taking only some dimensions from a Michelson plant and leaving others.

[00:42:47] Speaker 05:
And that's the theory

[00:42:48] Speaker 05:
that the board rejected absent a specific rationale.

[00:42:51] Speaker 03:
So it would require it if you have to find the ratio limitations in Telamon, et cetera, and the length in Michelson, then you have to combine them.

[00:43:01] Speaker 03:
If they're all in Michelson, you don't have to.

[00:43:03] Speaker 03:
So it's a different kind of analysis.

[00:43:06] Speaker 03:
Is that the idea?

[00:43:06] Speaker 03:
Yeah.

[00:43:07] Speaker 05:
It's a different type of analysis.

[00:43:09] Speaker 05:
And it doesn't answer the question of why you start with one type of implant that's designed a particular way and just

[00:43:15] Speaker 05:
and then turn to another implant and take some things but not others.

[00:43:19] Speaker 05:
The board in the context of allowing Claim 18 said you can't do that unless you give us a good rationale to do it and allowed Claim 18 to survive for that reason.

[00:43:29] Speaker 05:
The same assessment applies to the others.

[00:43:31] Speaker 01:
Okay, Mr. Rosado, your time is all up, so that concludes our hearing.